Coeliac disease
Coeliac disease is a lifelong immune disease caused by eating gluten; it shares many genetic and immunological features with autoimmune diseases and often coexists with autoimmune thyroid disease and type-1 diabetes. Gluten free diet is the only treatment. As gluten is commonly found in grains such as wheat, rye, and barley and often “contaminates” many foods, substantial lifestyle changes are needed for patients to ensure all gluten is removed from their diet.
Dr Bob Anderson of the Autoimmunity and Transplantation division has characterized the specific parts of the gluten that cause coeliac disease. This discovery has enable design of a therapeutic vaccine that may be able to protect patients from the damaging effects of gluten, and allow their return to a normal diet. To enable the drug development program to proceed Dr Anderson founded the biotech startup company, Nexpep. Nexpep and WEHI have a collaborative research agreement that has supported the drug development programme. Nexpep is commencing the first Phase 1 clinical trial of Nexvax2 April 2009. Forty coeliac disease patients will be given the vaccine to determine its safety and an appropriate dosing regime. The double-blind clinical trial will be undertaken at the specialist Phase 1 unit, Nucleus Network in Melbourne. Volunteers with biopsy proven celiac disease who possess HLA DQ2 but not HLA DQ8 and have followed a strict gluten free diet will be recruited. Five dose levels of Nexvax2 will be assessed. Volunteers will receive three doses of Nexvax2 over three weeks administered by intradermal injection. The trial will be complete by early 2010
The outcome of the Phase 1 trial will dictate if Nexpep will proceed with a Phase 2 trial, which would focus on ascertaining the clinical effectiveness of the treatment. The longterm goal is to have produced a safe, clinically effective treatment with minimal side effects that could be distributed worldwide to patients suffering from this debilitating ailment.
Dr Anderson is the CEO, CSO, Director and substantial shareholder in Nexpep Pty Ltd.